Data / Medical devices / United States / 3B Medical Inc
3B Medical Inc: FDA-registered device maker in Dublin, OH, United States, 20 510(k) clearances
3B Medical Inc is registered with the FDA (registration 3009096682) in Dublin, OH, United States. It lists 4 device types. The FDA files 20 510(k) clearances under its listings, the newest dated September 29, 2025. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009096682
- Address
- 5475 Rings Road Suite 550, Dublin, OH, United States, 43017
- Owner or operator
- React Health (10040143)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 22, 2020
- Registered through
- 2026
- Brand names listed
- DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL, DEVILBISS INTELLIPAP MODEL DV 5 SERIES, DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES, DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST, F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask, G3 B25VT, G3 B30VT, G3X APAP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Complaint file establishment | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Complaint file establishment | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2025 | K243833 | Portable oxygen concentrator (JAY-1000P) | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
| June 22, 2023 | K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | CAW | Substantially Equivalent | Qingdao Kingon Medical Science and Technology Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K213210 | Oxygen Concentrator, Model JAY-5AW | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
| December 5, 2022 | K213169 | BPAP System | MNS | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| March 25, 2022 | K212263 | Luna G3 BPAP System | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| March 9, 2022 | K211155 | Auto CPAP System | BZD | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| June 1, 2018 | K172234 | Oxygen Concentrator | CAW | Substantially Equivalent | Sysmed (China) Co., Ltd. | accessdata.fda.gov |
| September 5, 2017 | K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | BZD | Substantially Equivalent | Bmc Medical., Ltd. | accessdata.fda.gov |
| November 10, 2016 | K160127 | iCodeConnect | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| September 8, 2016 | K153387 | Luna CPAP and Auto CPAP System | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| September 18, 2015 | K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | BZD | Substantially Equivalent | Devilbiss Healthcare, LLC | accessdata.fda.gov |
| August 25, 2014 | K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| December 23, 2013 | K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| December 6, 2013 | K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| February 16, 2012 | K112271 | 3B WILLOW | BZD | Substantially Equivalent | 3B Products, LLC | accessdata.fda.gov |
| November 22, 2011 | K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL | BZD | Substantially Equivalent | Devilbiss Healthcare, LLC | accessdata.fda.gov |
| January 26, 2010 | K093070 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES | MNS | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| September 28, 2009 | K091919 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST | BZD | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
| November 10, 2008 | K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | DQA | Substantially Equivalent | Contec Medical System Co., Ltd. | accessdata.fda.gov |
| September 7, 2007 | K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES | BZD | Substantially Equivalent | Sunrise Medical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 4, 2026 | 98563 | Class II | Ongoing | React Health PHOENIX 5L Oxygen Concentrator | Devices which did not meet internal quality specifications were inadvertently distributed. | accessdata.fda.gov |
| November 27, 2024 | 95918 | Class II | Ongoing | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators | The devices were inadvertently shipped after their expiration date. | accessdata.fda.gov |
| June 15, 2023 | 99247 | Class II | Ongoing | Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for u | Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Ventilator, Continuous, Non-Life-Supporting
- All makers of Generator, Oxygen, Portable
- All makers of Oximeter
Updated April 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.